Director, Global Regulatory Affairs CMC

Takeda • Boston, MA

22d • Hybrid

About The Position

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: Independently develops the regulatory CMC strategy and leads the execution of regulatory CMC investigational, registration and post-approval strategies for their assigned product(s) as the GRA CMC Product Lead. Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred. Represents and contributes to Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and the commercial lifecycle. Demonstrate a high level of leadership and expert understanding of GRA CMC regulations and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience, precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners. Successfully communicates and negotiates with Health Authorities – directly and indirectly. Able to apply expert GRA CMC knowledge to address and overcome challenges that arise during development and commercialization. Acts as mentor / coach to other GRA CMC members.

Requirements

• BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) required.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years pharmaceutical Regulatory CMC and / or devices experience, while leading major submissions during LCM, development – including preparation of NDA/BLA/MAA.
• Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
• Strong understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Analyze issues with attention to detail.
• Ability to assess alternative approaches.
• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines
• Able to deal with issues of critical importance with minimal oversight.
• Exercises good judgment in elevating and communicating actual or potential issues to line management.
• Applies direction taken by the company.
• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
• Intentionally promotes an inclusive culture.
• Applies given prioritization framework with limited support.
• Excellent written and oral communication skills required.
• Exercises good judgement in elevating and communicating actual or potential issues to line management.

Nice To Haves

• Prior experience in leading or playing a major role in preparing the CMC aspects of global registrational submissions of complex drug product or suite of products is preferred.

Responsibilities

• Develops, executes and oversees the preparation of major global registrational submissions.
• Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.
• Ability to understand the overall product strategy and anticipate future challenges
• Represents Takeda GRA CMC in Health Authority meetings and drives preparation activities for meetings with Health Authorities on CMC related matters.
• Provide guidance to the teams on administrative procedural topics while interacting with International Heath Authorities - as required.
• Fosters constructive working relationships when interacting with internal and/or external colleagues.
• Providing strategic input into change control evaluation - as required.
• As a GRA CMC member, ensures and / or enhances regulatory compliance.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Reviews, provides regulatory CMC input and approves – as needed – technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards.
• When in a GRA CMC Product Team lead role, prepares and maintains relevant regulatory documentation (e.g., technical regulatory strategy documents, storyboards, risk assessments, etc.) and provides tactical regulatory guidance to product teams in line with global regulatory strategies.
• Accountable for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.
• Proactively identifies regulatory CMC risks, ensuring timely communication with line management.
• Leads assigned global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, etc.) through product lifecycle.
• Provides global regulatory input and support on product-compliance related activities including change controls, deviations, and investigations.
• Works effectively across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA sub-functions (e.g., Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies are implemented and project execution is on target.
• Supports development of strategies, tools, and trainings to further the GRA CMC roadmap.
• Proactively communicates CMC regulatory strategies, key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC, GRA, PS, GMS and QA - as appropriate.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Director